ARCPM 1050 RESIN-HIPS

• K Number: K023357
• Device Name: ARCPM 1050 RESIN-HIPS
• Manufacturer: BIOMET ORTHOPEDICS, INC.
• Date Cleared: 2002-11-06 ( 30 days)
• Product Code: LPH , JDI , LZO
• Regulation Number: 888.3358
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K950761 , K920640 , K926107 , K920639 , K921274 , K954417 , K970501
• Predicate For: K042051 , K042989 , K050327 , K062997 , K181491

Intended Use

The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:

1. NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2. Rheumatoid arthritis,
3. Correction of functional deformity,
4. Revision procedures where other treatments or devices have failed and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques.
   For Cemented and Non-cemented use

The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2. Rheumatoid arthritis,
3. Correction of functional deformity,
4. Revision procedures where other treatments or devices have failed and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
   For Cemented use only

The products found in the original 510(k) K921274 will use the following Indications for Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
2. Rheumatoid arthritis,
3. Correction of functional deformity,
4. Revision procedures where other treatments or devices have falled and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
   For Non-Cemented use only

The products found in the original 510(k) K970501 will use the following Indications for Use:
Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.
The device is a single use implant

Device Description

Biomet's polyethylene components are manufactured from UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin is isostatically compression molded under constant temperature and pressure and formed into acetabular components, which are designed to replace the articulating portion of the hip joint.

AI/ML Overview

This document is a 510(k) summary for the Biomet ArCom® Polyethylene Liners and Components. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel device. Therefore, a direct answer to the request to describe acceptance criteria and a study proving a device meets these criteria in the context of AI/ML evaluation cannot be fully provided from the given text.

However, I can extract the relevant information from the document that pertains to how the device's equivalence and safety were established.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of acceptance criteria and the reported device performance:

This document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, not on setting new acceptance criteria and proving performance against them for a novel device. The "acceptance criteria" here would be demonstrating that the new device is as safe and effective as the predicate devices.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Non-Clinical Testing)
Material composition (UHMWPE GUR 1050 resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2) is equivalent to or better than predicate device material (1900H).	The UHMWPE (GUR 1050) resin was confirmed to conform to ASTM F-648, ISO 5834-1, and ISO 5834-2.
Devices' technological characteristics (materials, design, sizing, and indications) are similar or identical to predicate devices.	Summarized as "similar or identical to the predicate device."
Performance in mechanical and aging tests meets or exceeds current standards/guidelines.	Process Validation: Tensile, impact, and physical properties met or exceeded current standards or guidelines. Hip Simulator: Met or exceeded current standards or guidelines. Aging behavior: Met or exceeded current standards or guidelines. Shelf life: Met or exceeded current standards or guidelines.
Indications for Use (IFU) are substantially equivalent to predicate devices.	The IFUs for the ArCom® Polyethylene Liners and Components (for various models and uses - cemented, non-cemented) were determined to be substantially equivalent to those of several predicate devices (K920640, K926107, K920639, K921274, K950761, K954417, K970501).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human "test set" data (clinical data) was used. The evaluation was primarily based on non-clinical (laboratory/mechanical) testing of the material.
• Data Provenance: The non-clinical testing was performed by Biomet, Inc. (Warsaw, IN, USA). This is laboratory/bench testing data, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" establishment by experts in the context of clinical data was performed, as no clinical studies were submitted. Substantial equivalence relies on comparing the device's technical characteristics and non-clinical performance to legally marketed predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set data requiring adjudication was provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical implant (hip joint component) and not an AI/ML software. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this 510(k) context is the established safety and efficacy of the predicate devices and the conformity of the new device's material and performance to recognized standards and guidelines. For the non-clinical testing, the "ground truth" is based on the performance according to these established standards (ASTM F-648, ISO 5834-1, ISO 5834-2) and the results of the specific physical tests (tensile, impact, physical properties, hip simulator, aging behavior, shelf life).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. Not an AI/ML algorithm.

Summary

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023357

BIOMET

6 2002 NOV

SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:	Biomet, Inc.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Tracy J. Bickel(574) 267-6639
Proprietary Name:	ArCom® Polyethylene Liners and Components
Common Name:	UHMWPE
Classification Name:	-hip joint metal/polymer semi-constrained porous coated uncemented prosthesis(888.3358)-hip joint metal/polymer semi-constrained cemented prosthesis (888.3350)- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (888.3353)
Substantially Equivalent Devices:	Please see the attached page(s) for the specific equivalent devices.
Device Description:	Biomet's polyethylene components are manufactured from UHMWPE (GUR1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resinis isostatically compression molded under constant temperature and pressure andformed into acetabular components, which are designed to replace the articulatingportion of the hip joint.
Indications for Use:	Please see the attached page(s) for the specific indications for use statements.
Summary of Technologies:	The UHMWPE resin has been changed from 1900H to GUR 1050. Thedevices' technological characteristics (materials, design, sizing, andindications) are similar or identical to the predicate device.
Non-Clinical Testing:	The following verification activities were performed on GUR 1050 resin: ProcessValidation (tensile, impact, and physical properties), Hip Simulator, Aging behaviorand shelf life. All of which met or exceeded current standards or guidelines;therefore, substantially equivalent to the predicate device.
Clinical Testing:	None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

1

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

를

OFFICE 574.267.6639

E-MAIL [e-mail]

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比023357

p. 2 of 3

SS&E Page 2
ArCom® Polyethylene Liners and Components

510(k)Number	Device Description	Indications for Use
K920640K926107	Ringloc UHMWPE Hi-Wall22, 26, 28, and 32 mmRingloc UHMWPE 10°22, 28, and 32mm	1. Noninflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis,2. Rheumatoid arthritis,3. Correction of functional deformity,4. Revision procedures where other treatments ordevices have failed and5. Treatment of nonunion, femoral neck andtrochanteric fractures of the proximal femur withhead involvement, unmanageable using othertechniques.
K920639	RX 90 std. Hi-Wall28mmRX 90 +5 Deep28mm	For Cemented use only
K921274	Impact Hi-Wall28 and 32mm	1) Noninflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis,2) Rheumatoid arthritis,3) Correction of functional deformity,4) Revision procedures where other treatments ordevices have failed and5) Treatment of nonunion, femoral neck andtrochanteric fractures of the proximal femur withhead involvement, unmanageable using othertechniques.For Non-Cemented use only
K926107	Mod. Hi-Wall LNR28 and 32mmMod. 10° LNR28 and 32mmRX 90 std. Hi-Wall28mmRX 90 +5 Deep28mm	1. Noninflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis,2. Rheumatoid arthritis,3. Correction of functional deformity,4. Revision procedures where other treatments ordevices have failed and5. Treatment of nonunion, femoral neck andtrochanteric fractures of the proximal femur withhead involvement, unmanageable using othertechniques.For Cemented use only
510(k)Number	Device Description	Indications for Use
K950761	Ringloc UHMWPE Hi-Wall22, 26, 28, and 32 mmRingloc UHMWPE 10°22, 28, and 32mmRingloc LP Hi-WallArcom22, 28, and 32mmRingloc Arcom LP 10°22, 28, and 32mm	1. Noninflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis,2. Rheumatoid arthritis,3. Correction of functional deformity,4. Revision procedures where other treatments ordevices have failed and5. Treatment of nonunion, femoral neck andtrochanteric fractures of the proximal femur withhead involvement, unmanageable using othertechniques.
K954417	Arcom +5mm	For Cemented and Non-cemented use
K950761K954417	Arcom Std. Face28and 32mmArcom Hi-Wall22, 26, 28, and 32mmArcom 10°22, 26, 28, and 32 mm
	Arcom 10° Hi-Wall28 and 32mm
K970501	Arcom Std. Face28 and 32mmArcom Hi-Wall22, 26, 28, and 32mmArcom 10°22, 26, 28, and 32 mmArcom 10° Hi-Wall28 and 32mmArcom +528mm	Intended for use in reconstruction of the hip joint dueto disease, deformity of trauma. The device is intendedfor cemented application for general use and non-cemented application in skeletally mature individualsundergoing primary surgery for rehabilitating hip jointsdamaged as a result of non-inflammatory degenerativejoint disease or any of its composite diagnoses.Single use implant

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023357

SS&E Page 3
ArCom® Polyethylene Liners and Components

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are evenly spaced.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K023357

Trade/Device Name: ArCom® Polyethylene Liners and Components Regulation Number: See Enclosed List Regulation Name: See Enclosed List Regulatory Class: Class II Product Code: See Enclosed List Dated: October 4, 2002 Received: October 7, 2002

Dear Ms. Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

2002

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Tracy J. Bickel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D.
Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

(1) Indications for Use Forms (4 pages)

(2) Classification Table (2 pages)

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EnclosurE :

politici fi ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Product	ProductCode	ClassificationNomenclature	Class.Code	510(k)
Ringloc UHMWPE Hi-Wall22, 26, 28, and 32 mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761
Ringloc UHMWPE Hi-Wall22, 26, 28, and 32 mm	JDI	JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K920640K926107
Ringloc UHMWPE 10°22, 28, and 32mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761
Ringloc UHMWPE 10°22, 28, and 32mm	JDI	JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K920640K926107
Ringloc LP Hi-Wall Arcom22, 28, and 32mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI-hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761
Ringloc Arcom LP 10°22, 28, and 32mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761
Arcom Std. Face28and 32mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761K970501K954417
Arcom Hi-Wall22, 26, 28, and 32mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761K970501K954417
Arcom 10°22, 26, 28, and 32 mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761K970501K954417
Arcom 10° Hi-Wall28 and 32mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesisJDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3358888.3350	K950761K970501K954417
Product	ProductCode	ClassificationNomenclature	Class.Code	510(k)
Arcom +528mm	LPH andJDI	LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesis	888.3358	K970501
		JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K954417
Mod. Hi-Wall LNR28 and 32mm	JDI	JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K926107
Mod. 10° LNR28 and 32mm	JDI	JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K926107
RX 90 std. Hi-Wall28mm	JDI	JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K920639K926107
RX 90 +5 Deep28mm	JDI	JDI- hip joint metal/polymer semi-constrained cementedprosthesis	888.3350	K920639K926107
Impact Hi-Wall28 and 32mm	LZOLPH	LZO- prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented	888.3353888.3358	K921274
		LPH- hip joint metal/polymer semi-constrained porouscoated uncemented prosthesis

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Enclosure :

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Page 1 of 4.

KU23357 510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use:

• 1. NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• 2. Rheumatoid arthritis,
• 3. Correction of functional deformity,
• 4. Revision procedures where other treatments or devices have failed and
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques.

For Cemented and Non-cemented use

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter-Use_ (Optional Format 1-2-96)

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Page 2 of 4.

510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• Rheumatoid arthritis, 2)
• 3. Correction of functional deformity,
• 4. Revision procedures where other treatments or devices have failed and
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

For Cemented use only

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use_ (Optional Format 1-2-96)

Muriam C. Provost
(Division Sign Off)

(Division Sien-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023357

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Page 3 of 4

20233 510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K921274 will use the following Indications for Use:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• Rheumatoid arthritis,
• Correction of functional deformity,
• Revision procedures where other treatments or devices have falled and
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

For Non-Cemented use only

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023357

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Page of

02335 510 (k) Number (if known) :

Device Name: Arcom® Polyethylene Liners and Components

Indications for Use: The products found in the original 510(k) K970501 will use the following Indications for Use:

Intended for use in reconstruction of the hip joint due to disease, deformity of trauma The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses.

The device is a single use implant

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023357

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.